Conference Day 1: FDA Inspections Summit

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17TH ANNUAL

FDA Inspections Summit

FDA Inspections Summit

#1 Event for Quality, Compliance and Regulatory Professionals

Wednesday, November 16, 2022 - Friday, November 18, 2022
Park Hyatt, Washington, DC

Nov. 16 - 18, 2022
Park Hyatt, Washington, DC

Agenda

Wednesday, November 16, 2022

Thursday, November 17, 2022

Friday, November 18, 2022

Thursday, November 17, 2022 – Conference Day 1

8:00 AM

Registration & Continental Breakfast

9:00 AM

Welcoming Remarks

9:15 AM

Keynote Address — The FDA Perspective on Inspections: What’s Happening Now and What to Expect in 2023

10:00 AM

Auditing Manufacturers: Linking Data Integrity with Quality Culture

10:45 AM

Refreshment and Networking Break

Breakout Tracks

11:00 AM

Clinical Trials

Purpose Driven Inspection Preparedness: People, Process and Technology — Critical Components to Success

Drugs & Biologics

How to Ensure Your Drug or Biologics Manufacturing Facility Is Ready to be Evaluated by the FDA Either Remotely or In-Person

Medical Devices

Cybersecurity: The Current Regulatory Landscape and How to Defend Your Practices During an Inspection

12:30 PM

Breakout Tracks

1:30 PM

Clinical Trials

The Potential — and Limitations — of Technology-Driven TMF Compliance

Drugs & Biologics

The Impact of AI and New Technology

Medical Devices

The Impact of AI and New Technology on Regulatory Compliance

2:30 PM

Refreshment and Networking Break

Breakout Tracks

2:45 PM

Clinical Trials

BIMO in Action: AQC Members Share Insights from Their Recent Inspection Experiences

Drugs & Biologics

Lessons Learned from COVID-19 & Supply Chain Mayhem

Medical Devices

FDA’s Shift from QSR to ISO 13485:2016: A Significant Change for Inspections

3:30 PM

Refreshment and Networking Break

3:45 PM

Validating Your Systems and Equipment for Compliance

4:30 PM

Mock Inspection: Practice Makes Perfect

5:30 PM

Networking Reception

View the full three-day schedule

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA
Phone 703.538.7600 - Fax 703.538.7676 - Toll free 888.838.5578

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